ECM for Pericardial Closure

ECM for Pericardial Closure enables surgeons to re-establish the essential native anatomic structure of the pericardium.

ECM for Pericardial Closure is used to restore the pericardium by providing a natural bioscaffold that allows the patient’s own cells to form a new pericardial layer.1,2 Absence of the pericardial barrier often leads to scarring and the formation of adhesions between the heart and sternum, impairing normal heart function.1,3,4,5,6 Reconstructing the pericardium facilitates less bleeding and re-exploration, safer re-entry, and may shorten operative times for redo.4,7,8 Reformation of the pericardium using ECM enables surgeons to re-establish this essential native anatomic structure.1

Benefits:

  • Remodels over time to restore healthy, pericardial tissue1
  • Preserves the distance between the heart and sternum3
  • May shorten operative times for redo procedures9
  • Enables accurate identification of post-operative bleeding10
  • Lacks the pro-inflammatory components of chemically fixed xenografts3
  • May improve hemodynamics by restoring normal anatomy11

Ordering Information

Product Number Size Thickness
CMCV-003-401 7cm x 10cm 4-PLY
CMCV-003-402 7cm x 15cm 4-PLY
CUSTOMER SERVICE AND ORDERING:
customerservice@aziyo.com         877-651-2628

REFERENCES

  1. Stelly M et al.Ann Thorac Surg. 2013 Nov;96(5):e127-9.
  2. Sundermann S et al. Thorac Cardiovasc Surg. 2014 Feb;62(1):76-9.
  3. Boyd W et al. Expert Rev Cardiovasc Ther. 2012 Sep;10(9):1109-18.
  4. Rao V et al. Should the pericardium be closed routinely after heart operations?. Ann. Thorac. Surg. 67(2), 484–488 (1999).
  5. Bittar M et al. Interact Cardiovasc Thorac Surg. 2005 Apr;4(2):151-5.
  6. Morales D et al. Interact Cardiovasc Thorac Surg. 2010 Sep;11(3):277-86.
  7. Bahn C et al. Pericardial Closure. Am J Surg. 1986 May;151(5):612-5.
  8. Rego A et al. Presented at ACC 2017 Scientific Sessions.
  9. Singh T et al. The Internet Journal of Thoracic and Cardiovascular Surgery. 2007 Volume 12 Number 2.
  10. Spodick. Intrapericardial Therapy and Diagnosis. Curr Cardiol Rep. 2002 Jan;4(1):22-5.
  11. Kroeker C et al. Am J Physiol Heart Circ Physiol. 2003 Jun;284(6):H2247-54.

ECM for Cardiac Tissue Repair

ECM is our next generation tool for repair of intracardiac structures. Regrowth and remodeling capabilities make it superior to inert patches that ultimately promote inflammation and scarring.

ECM for Cardiac Tissue Repair is intended for use as an intracardiac patch or pledget for tissue repair (i.e. atrial septal defect [ASD], ventricular septal defect [VSD], etc.) and suture-line buttressing.  It may be used to repair intracardiac tissues, damaged cardiac structures, or during procedures when cardiovascular prosthetics (such as valves) do not fit properly. ECM is ideal for intracardiac surgery based on its ability to structurally support repairs and remodel tissue. In cases such as ASD repair, ECM for Cardiac Tissue Repair can effectively close a hole and generate new, healthy tissue in lieu of using objects such as nitinol plugs or synthetic patches. ECM is gradually replaced by native tissue as it remodels.

Benefits:

  • Effectively closes holes and restores natural cardiac tissue
  • Ideal for intracardiac repairs
  • Encourages the body’s natural immune response, unlike synthetic grafts1,2
  • Allows capillary in-growth and infiltration3,4,5,6
  • Resists calcification7,8,9,10

Ideal Uses for ECM for Cardiac Tissue Repair:

  • ASD Repair
  • VSD Repair
  • Aortic Root Enlargement
  • Left Ventricular Aneurysm Repair
  • Sinus of Valsalva Aneurysm
  • Repair of Cardiac Tumors
  • Endocarditis
  • Use as a Pledget
  • Suture-Line Buttressing

Ordering Information

Product Number Size Thickness
CMCV-004-401 7cm x 10cm 4-PLY
CMCV-004-404 4cm x 7cm 4-PLY
CUSTOMER SERVICE AND ORDERING:
customerservice@aziyo.com         877-651-2628

REFERENCES

  1. Piterina A et al. Int J Mol Sci. 2009 Nov 20;10(10):4375-417.
  2. Additional references on file
  3. Shell D et al. Ann Surg. 2005 Jun;241(6):995-1001; discussion 1001-4.
  4. Sundermann S et al. Interact Cardiovasc Thorac Surg. 2015 Jan;20(1):10-4.
  5. Li F et al. Endothelium. 2004 May-Aug;11(3-4):199-206.
  6. Badylak S et al. J Surg Res. 2002 Apr;103(2):190-202.
  7. Sundermann S et al. Thorac Cardiovasc Surg. 2014 Feb;62(1):76-9.
  8. Fallon A et al. J Surg Res. 2012 Jun 1;175(1):e25-34.
  9. Gerdisch M et al. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1370-8.
  10. Padalino M et al. Interact Cardiovasc Thorac Surg. 2015 Jul;21(1):40-9; discussion 49.

Tyke® is the only ECM specifically cleared for use in neonates and infants.

Tyke was developed based on a request by Pediatric Cardiovascular Surgeons to deliver an ECM material that maintained the biomechanical properties found in our existing products, but was thinner, more pliable and better suited for intracardiac and branch pulmonary artery use in neonates and infants.1

Tyke is intended for use in neonates and infants for the repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair. Tyke meets the same biomechanical requirements (tensile strength, suture retention strength and burst strength) as our existing ECM for Cardiac Tissue Repair, and bench testing has shown that Tyke exceeds the specified tensile strength, suture retention strength, and burst strength required for its intended surgical use.2

To assess the biological performance of Tyke, patches were implanted in the descending aorta and pulmonary artery of a growing lamb model.3 Explanted patches were evaluated by an independent, board-certified pathologist. Tyke was found to restore the structural integrity (including the formation of a mature, stable, and fully endothelialized neointima) of the implant site within 90 days (Figure 1). By 180 days, the thickness of the remodeled Tyke patch was similar to the thickness of the adjacent native artery.

Ordering Information

Product Number Size Thickness
CMCV-099-204* 4cm x 7cm 2-PLY
 *Product available for U.S. customers only.

 

CUSTOMER SERVICE AND ORDERING:
customerservice@aziyo.com         877-651-2628

REFERENCES

  1. Padalino M et al. Interact Cardiovasc Thorac Surg. 2015 Jul;21(1):40-9; discussion 49.
  2. In-house testing
  3. Animal Model

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